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Acarix has announced that the FDA is reviewing a de novo 510(k) application for its innovative CADScor cardiac diagnostic device. This is important news as it could mean that Acarix might enter the US market by 2021 – although it will need marketing alliances and good reimbursement. Given weak European sales and no update on German reimbursement, accessing the large US market could radically transform the business. Acarix might need US clinical data to ensure that it gains Medicare and insurer r
Companies: Acarix AB
Edison
Acarix has competed a rights issue of 28.67m shares at SEK1.50/share to raise SEK43m before expenses. The proceeds will fund a programme of market development and clinical trials. The process for German public reimbursement is underway. In the UK, NICE has carried out a technical assessment enabling a dialogue to start. Acarix is now developing a US market entry strategy and assessing the likely FDA trial needs.
CADScor H1 unit sales were to Germany (six), Sweden (three) and Denmark (one). Interestingly, Q219 patch sales were very strong at 1,690 up from 640 in Q119. These 1000 ‘extra’ sales could be an indication that users are starting to run more tests from the installed CADScor base. The process for German public reimbursement is underway. In the UK, NICE has done a technical assessment enabling a dialogue to start. Acarix is now developing a US market entry strategy and the likely FDA trial needs.
Acarix has gained strong support from clinical users, one comments that CADScor will ‘shorten waiting lists and add value for both patients and healthcare system’. The CADScor medical device helps doctors rule out coronary artery disease, avoiding complex and costly further testing in 50% of cases. Q119 sales were SEK299k with a gross profit of SEK209k, a 70% margin. Acarix sells to the German and Austrian private markets (about 10% of the population) and the Scandinavian public sector. The proc
The CADScor medical device helps doctors rule out coronary artery disease and so avoids complex and costly further testing in 50% of cases. Acarix is in a market development phase; FY18 results show CADScor sales of SEK1m. The application for German public reimbursement is underway; more news is expected in mid-2019. Acarix is focused on the German private market (about 10% of the population) plus public sector sales in Scandinavia. The significant long-term sales potential remains unaltered, bu
Acarix’s Q3 results showed a marked upturn in the number of systems sold: seven in Q3 vs eight in H1. Disposable patch sales in Q3 were 680 vs 800 in H1. These sales generated Q3 revenues of SEK351k. We have adjusted our sales forecast upwards to SEK1.3m for the full year 2018. Feedback from German and Swedish customers has been very positive. German public reimbursement might occur in 2019. We do not expect a US launch before 2022 and we assume a US trial starts in 2019 to enable this. Per Pers
Acarix’s H1 results show steady sales with eight systems and 800 disposable patches sold to June. These generated H1 revenues of SEK465k with gross profit of SEK349k, a 75% average margin. We now expect sales of just over SEK1m for the full year 2018 before hoped-for German reimbursement in 2019. A new commercial officer, Per Persson, has joined. We do not expect a US launch before 2022 and we assume a US trial starts in 2019. The indicative value remains SEK448m (SEK19.46/share). Additional cli
Acarix’s Q1 update shows sales of four systems to March. Revenues were SEK230k with gross profit of SEK158k; a gross margin of 69%. We do not expect any major sales upturn in 2018, as the key factor is German government reimbursement, which is not expected before 2019. There is additional sales potential in other European territories. We do not expect a US launch before 2022, but we have assumed a US trial starts in 2019. The indicative value remains at SEK448m (SEK19.46/share). Additional clini
Acarix’s annual report confirms reported 2017 revenues of SEK638k. Gross profit was SEK430k, with a gross margin rise to 75% in Q4. We do not expect any major sales upturn in 2018, as the key factor is German government reimbursement – this is not expected before 2019. There is additional sales potential in other European territories. We do not expect a US launch before 2022, but we have assumed a US trial starts in 2019. The indicative value remains at SEK448m (SEK19.46/share). Mr Lindholm is t
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Cambridge Nutritional Sciences (CNS) has provided a trading update for the 12 months to 31 March 2024, noting that a combination of strong sales growth and significant margin improvements, driven by operational efficiencies, have played key factors in the group’s expectation of being adjusted EBITDA positive in FY 2024. Revenues are expected to be £9.8m (30% YoY growth), ahead of our £9.0m forecast, with gross profits expected to exceed £6m, which is again ahead of our year-end forecast of £5.6m
Companies: Cambridge Nutritional Sciences PLC
Cavendish
Companies: Warpaint London PLC
Shore Capital
Cambridge Nutritional Sciences (CNS) has published its H1 2024 results to end September 2023. Group revenues grew 44% to £4.9m and gross profits increased by 63% to £3.1m, with the company benefitting from newfound operational efficiencies. With its now streamlined strategy focussing on the core Health & Nutrition business and the initial signs of an encouraging uptick in sales momentum, we believe the company is well positioned for growth that will help create future value for shareholders. We
22nd April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to acquire the entire issued share capital of 3radi
Companies: ARV CTL AFRN FEN HUW TENG BBSN EAAS VAL
Hybridan
Feature article: Steady as she goes, but could be better: A review of investment company liquidity since 2016 Liquidity is the lifeblood of equity markets. The measurement of liquid asset availability to a market or company is a way of gauging a market’s health. This article builds on our previous work, which analysed the liquidity data for non-financial trading companies, by applying the same analytical techniques to the investment companies (IC) space. We analyse liquidity for ICs as a whol
Companies: NBPE ICGT ARBB RECI CLIG HAT AVO VTA APAX
Hardman & Co
17th April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to acquire the entire issued share capital of 3radi
Companies: ARS TIDE SCE SNX ECK CNS TST SPEC SSTY
Companies: IGP RUA BOOM
Venture Life has reported FY23 results to December 2023, following the February trading update. Revenues grew 17% in the year to £51.4m (our est. £50.7m) and adjusted EBITDA was £11.6m (our est. £11.6m). Cash conversion was 85%, generating £9.8m of cash from operations. Cash generation and no M&A in 2023 allowed the company to de-lever, closing FY23 with net debt to adjusted EBITDA at 1.3x. Management have focused on growth with three therapy areas generating double-digit revenue growth and onli
Companies: Venture Life Group Plc
At its recent capital markets day (CMD) and with the support of key opinion leaders, Basilea highlighted the rising need for innovative therapies to address serious fungal and bacterial infections. It continues to make advancements in this specialised segment through the development of opportunistic acquisitions leveraging its anti-infective expertise. Its growth initiatives remain funded through the traction of its commercialised products, Cresemba and Zevtera. FY24 key strategic priorities inc
Companies: Basilea Pharmaceutica AG
The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (
Companies: TXG NDVA TSVT BCOW Z29 TXG NCYT GNS SUN AMS OMG APH EKF EAH IMM AGL DEMG AGY TSTL IPO GDR ETX TRX HVO CTEC AVO OXB DEST VLG IXI VAL INDV AGR AVCT BAI 123F IMCR BCOW
Companies: BILN IGP RBN SBTX
Companies: PureTech Health PLC
Liberum
Creo Medical has received US FDA approval for its Speedboat UltraSlim device, which will enable the company to launch it in the coveted US market. Though expected, this marks a material regulatory win for Creo as UltraSlim is the company’s thinnest and most versatile device and it is now projected to be available in both Europe (via accelerated EU regulatory pathway) and the US in 2024. The UltraSlim device remains an important addition to the portfolio as it provides broader access to gastroint
Companies: Creo Medical Group Plc
Cizzle Biotechnology (Cizzle), focused on cancer diagnostics, was spun out of the University of York to exploit the biomarker, variant CIZ1b, for the early detection of different forms of lung cancer. While implementing this strategy over the past year, Cizzle’s interest has been broadened to include early detection of other cancers and companion diagnostic tests that can assist in the development and use of personalised medicines. In the 12 months since listing, Cizzle has secured key partners
Companies: Cizzle Biotechnology Holdings PLC
Dish of the day Joiners: No joiners today. Leavers: No leavers today. What’s cooking in the IPO kitchen?** 9 November: Chapel Down Group ITF: England's leading and largest wine producer with an award-winning range of sparkling and still wines, under the Chapel Down brand. The Company owns, leases and sources from 1,023 acres of vineyards in South East England announces its Admission to AIM after its transfer from the Aquis Apex market. The Company will not be raising new capital or providing a s
Companies: CLBS NTBR YNGA TGP MANO POLB AURR
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